Catalog Number

-

Brand Name

FloPatch

Version/Model Number

FP120

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K200337,K200337,K200337,K200337

Product Code

DPW

Product Code Name

Flowmeter, Blood, Cardiovascular

Public Device Record Key

e5f756c4-4531-41aa-9ad2-5381a91410b6

Public Version Date

August 27, 2021

Public Version Number

3

DI Record Publish Date

September 22, 2020

Package DI Number

10627987360100

Quantity per Package

10

Contains DI Package

00627987360103

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box